100% PURE YERBA MATE MIST SPF 30- zinc oxide aerosol, spray

100% Pure Yerba Mate MIst by

Drug Labeling and Warnings

100% Pure Yerba Mate MIst by is a Otc medication manufactured, distributed, or labeled by Purity Cosmetics, Bell International Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Zinc Oxide 12%

Purpose

Sunscreen

Uses

• Helps prevent sunburn.
• If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early aging caused by the sun.

Warnings

• Contents under pressure. Do not puncture or incinerate.
• ​For external use only
• Do not spray directly on face.
• Do not use ​on damaged or broken skin.
• ​S top use and ask a doctor ​if rash occurs.
• When using this product​ keep out of eyes. Rinse with water to remove.

WHEN USING

When using this product, keep out of eye. Rinse with water to remove.

KEEP OUT OF REACH OF CHILDREN

​ Keep out of reach of children. ​If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Do not spray directly onto face. Spray into hands and rub onto your face.
• To ensure adequate sun protection, avoid spreading too thinly when applying.
• Shake well before use.
• Apply liberally 15 minutes before sun exposure.
• Reapply: after 80 minutes of swimming or sweating / immediately after towel drying / at least every 2 hours
• Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
• Limit time in the sun, especially from 10 a.m. - 2 p.m.
• Wear long-sleeved shirts, pants, hats and sunglasses.
• Children under 6 months: Consult a physician.

Other Ingredients

Bentonite, Butyloctyl Salicylate, Caprylhydroxamic Acid, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Seed Oil, Cetearyl Alcohol, Coco Glucoside, Glycerin, Heptyl Undecylenate, Ilex Paraguariensis (Yerba Mate) Leaf Extract, Jojoba Ester, Methyl Dihydroabietate, Water

Other information

Protect this product from excessive heat and direct sunlight.

Questions or comments?

call 1.844.787.3100 or visit www.100PercentPure.com

100% Pure Yerba Mate Mist SPF 30

INGREDIENTS AND APPEARANCE

100% PURE YERBA MATE MIST  SPF 30
zinc oxide aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52667-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	120 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
COCO GLUCOSIDE (UNII: ICS790225B)
HEPTYL UNDECYLENATE (UNII: W77QUB6GXO)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
SAFFLOWER OIL (UNII: 65UEH262IS)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)
BENTONITE (UNII: A3N5ZCN45C)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52667-006-96	96 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	05/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/01/2017

Labeler - Purity Cosmetics (055795259)

Establishment
Name	Address	ID/FEI	Business Operations
Bell International Laboratories		967781555	manufacture(52667-006)